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Associate, RA - Post Approval

Application Deadline: June 29, 2019

Location: Schaumburg, ILLINOIS, USA

Job Summary / Overview:

Responsible for support of post-approval regulatory affairs activities under direction of the department Manager. Post-approval regulatory affairs activities may include but are not limited to::

  • Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling

  • Electronic assembly and publication of original applications, amendments, and supplements

  • Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.


Success in the role is measured by:

  • Timely and accurate pre-submission review and electronic filing of FDA submissions including ANDA’s, 505(b)(2)s, Amendments, Supplements, Annual Reports, DMF updates, labeling changes, and Advertising/Promotional material

  • Timely and accurate review of change controls according to regulatory guidelines.


Key Duties and Responsibilities:

  • Post-approval product support activities: Compilation and review of FDA Submissions (e.g., Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with partners; and change control review/approval;

  • Coordinate compilation/review of Advertising/Promotional material with Marketing for Manager’s review and approval. Submit Advertising/Promotional materials to FDA’s OPDP via electronic methods.

  • Domestic and international travel may be required.


Knowledge or Experience:

  • Experience in the use of PC-based word processing software, databases, spreadsheets and Adobe Acrobat, including database management and support.

  • Experience with metrics management and reporting.

  • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.


Minimum Qualifications / Experience:

  • 2 or more years of direct pharmaceutical industry experience OR equivalent experience working in a cGMP and/or FDA regulated environment is preferred.

  • Excellent communication skills with both internal and external stakeholders.

  • Strong planning and organizational skills.

  • Ability to work under deadline pressure, rapidly shifting priorities and manage multiple projects.

  • Strong ability to work independently as well as in a team environment.

  • Ability to drive projects to completion with minimal guidance.

  • Formal project management skills are a plus.


Education / Certifications:

Bachelor’s degree in a scientific area of interest (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing) or equivalent work experience.

 

SAGENT Pharmaceuticals, Inc. is committed to providing equal employment opportunities to all job candidates and employees without regard to unlawful consideration of race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by applicable law. This commitment extends to all terms and conditions of employment.  

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